The CRADA is the only mechanism by which a Federal
lab may consent to sharing of intellectual property (IP). The primary
difference between CRADAs and other PHS research agreements is that
CRADAs provide the commercial collaborator with an option, in advance,
to licenses on inventions made under the scope of the research plan
of the agreement. This is extremely important to commercial entities,
particularly in volatile and undercapitalized markets.
Like the CTA, the CRADA cannot be utilized to circumvent the Federal
Acquisition Regulations ( FAR), meaning that commercially available
products must be purchased or gifted, they cannot be attained through
a CRADA. Therefore, if a material is reasonably available commercially,
its supply to a federal lab cannot be the singular reason for the
There are two types of CRADAs, a Material CRADA (MCRADA) and a standard
CRADA (CRADA). The main difference between the two is that with
the MCRADA, there is no collaboration between the parties, only
an exchange of material, provision of resources, and possibly provision
of money by the commercial partner. Funding can be supplied by the
collaborating party to NINDS, but funds cannot be supplied by the
federal lab to an outside party. No funding ever flows from the
government lab to a commercial entity in a CRADA. However, supplementation
of one’s lab budget cannot be the motivating factor for a
CRADA or MCRADA, rather, the intent and scope of the research should
be well within the lab’s general research.
Typical types of exchanges can include:
The NINDS lab can contribute staff intellect, facility, or resources;
promise licensing rights to any discoveries made under the research
plan of the CRADA, and allow collaborators staff to work at the
NINDS facilities as visiting scientists while remaining employees
of the commercial collaborator.
The collaborator can contribute materials, equipment, facility,
staff, and monetary support. Selection of a CRADA partner has some
specific stipulations. Due to the Freedom of Information Act, a
CRADA opportunity has to be advertised to allow all potential collaborators
“access” to being considered. The only exception to
this is where a potential collaborator has a “proprietary”
product, meaning no other company can meet the requirements of the
The CRADA has a review process, so there is a longer time requirement
for the successful negotiation of a CRADA depending on its complexity
and whether it is a MCRADA or standard CRADA.
What Is Included In The CRADA Agreement?
For a CRADA , there is a “boilerplate” template which
contains the standard terms and conditions and to which is added
a well defined research plan, specification of each parties contributions
in personnel, intellectual property, and definition of any funding
provided by the collaborator. The federal lab may provide research
personnel, laboratory, facilities, materials, equipment, supplies,
and other in-kind contributions - but not funding - to the collaborator.
In general, the collaborator contributes personnel, equipment, materials
and funding. The collaborator also may contribute funds to cover
some of the added costs to the participating agency for work done
under the research program of the agreement. Ultimately, the collaborator
provides the know-how needed for development and commercialization
of a new product, process, or service that may arise from the collaboration.
For the MCRADA there is also a “boilerplate” template
which contains the standard terms and conditions. For a MCRADA,
the research plan is generally a brief summary followed by definition
of funding should any funding be provided.
Both forms of CRADA include a number of standard provisions based
on policy, regulatory and legal guidelines adopted by the PHS Agencies:
• Research, development, and commercialization efforts contemplated
for each party.
• Contributions of the PHS agency by way of equipment, supplies,
• Contributions of the commercial firm by way of equipment,
supplies, personnel, and funding.
• Publication of results
• Inventions, focusing on definitions, ownership, and patent
What Are The Benefits Of Utilizing the CRADA Process?
Collaboration under either a MCRADA or CRADA results in a number
of mutual benefits for PHS agencies and for commercial firms, as
well as expediting public access to the technology in the form of
a commercially available product.
The motivations for commercial entities to enter into CRADAs with
an NIH laboratory varies depending on the market sector and capitalization
of the company. CRADAs are the only mechanism by which a federal
lab can provide the commercial collaborator with an option, in advance,
to negotiate exclusive or non-exclusive licenses on inventions made
under the scope of the research plan of the agreement. When a PHS
agency enters into a C RADA, the research objective must be shown
to be consistent with the agency’s/lab’s mission. PHS
CRADAs do not seek "sponsorship" but rather, collaboration,
making CRADAs a very cost effective way for small businesses as
well as Pharma to leverage their own R&D efforts and for the
PHS labs to gain a pathway to commercialize their research and discoveries.
Commercial firms benefit by:
• Improved access to PHS researchers and facilities.
• Direct access to the expertise related to research results
• Options to exclusive licensee on inventions made under the
terms of the agreement
• Compressed schedule to production of a marketable product.
The NINDS researcher benefits from a CRADA
PHS agencies benefit by:
• Commercialization of products that benefit public health
and that otherwise would not be viable commercial products due to
market size or costs or research and development.
• Accelerated schedule to transfer basic science findings
into commercial products to benefit public health,
• Increased sensitivity to demands and costs of the process
of development and commercialization of products for the benefit
of the public health
• Sharing of royalties with PHS investigators as reward for
excellence in research leading to Public health benefit
Guidelines for Drafting a CRADA Research Plan
1. Goal of the CRADA
Identify (three to four sentences) the research goal(s) of this
CRADA including the respective research goals of the NIH and Collaborator
Principal Investigators. Explain why this project is important scientifically.
2. Detailed Description of the Research Plan:
The primary purpose of this Research Plan is to permit careful monitoring
of CRADA research projects by scientific and division directors
of our institutes, centers and divisions. An additional purpose
for the Research Plan is established by the Federal Technology Transfer
Act of 1986 (FTTA). Under the FTTA, the Parties' obligations to
each other in such areas as confidentiality and patent rights extend
only to "specified research or development efforts." This
statutory limitation will create the boundaries for license rights
to inventions made under the CRADA. Appropriate care should be taken
in drafting this Research Plan carefully and completely. The field(s)
of use to which Article VIII of this CRADA pertains will be limited
to the specified research or development efforts in view of the
foregoing research goals. The Collaborator further should bear in
mind that, although insubstantial changes in this Research Plan
may be made by mutual written consent of the Principal Investigators
under Article 7.4, substantial changes will require formal amendment
under Article 14.6 in order to maintain entitlement to invention
rights. Absent compelling justification for a failure to make the
original Research Plan complete, amendments will be made retroactive.
Therefore, please provide a description (two to five pages) of the
intended Research Plan in sufficient detail to permit reviewers
of this CRADA to evaluate the scientific merit of the proposed cc]
collaboration The Research Plan should be described in detail fn
terms of specific research projects not in terms of a general research
program or research goals. Contemplated initial and subsequent projects
should be summarized along with estimated time periods for their
completion. These projects, may he described sequentially in distinct
phases contingent upon the success of earlier phases. Important
methodological considerations should be noted, and citations to
pertinent literature references may be helpful.
3. Respective Contributions of the Parties
Under Paragraph 4 of the NIH "Policy Statement" ( Is this
available as URL?, CRADAs are authorized only with collaborators
who will make a significant intellectual contribution to the research
project undertaken, or who will contribute essential research materials
or technical resources not otherwise reasonably available to NIH.
CRADAS are not viewed by NIH as a general funding source or as a
mechanism for sponsored research. Thus, unless essential materials
or technical resources are involved, the Research Plan must indicate
clearly that a true intellectual collaboration will take place.
With regard to the detailed research plan required, identify in
detail by Party and by principal Investigator the respective contributions
of research, development, analysis, expertise, research materials,
and time that is to be committed to the various specified research
projects and their component steps.
4. Abstract of the Research Plan for Public Release:
In order to fulfill the NIH obligations regarding Fair Access, NIH
requires an abstract of the research that can be released upon request.
To protect the legitimate concerns of the Collaborator as to its
research agenda, the Collaborator is requested to assist in and
carefully review this abstract. Signature of this CRADA by the Collaborator
shall be deemed to be agreement by the Collaborator that NTH may
disclose this abstract publicly.
5. Related CRADAS:
The Collaborator should identify by Title, Principal Investigator
and Institute all other CRADAS that it has with NIH. The NIH Principal
Investigator should similarly identify all CRADAs that his or her
laboratory has with this or any other Collaborator.
6. Related MTAs
The NIH Principal Investigator carefully must review his or her
laboratory files and list any MTAs, from any source, that will provide
research materials used in earlier projects that relate directly
or indirectly to this CRADA, or that provided research materials
used to develop any materials to be studied or utilized in this
CRADA. The IC Technology Development Coordinator, utilizing the
central data base, will work with the PI to identify any agreements
processed by that office.
7. Related Patent Applications and Patents:
The NIH Principal Investigator and Technology Development Coordinator
should identify by title and serial number any IC patent applications
and Patents that are directly or indirectly related to the subject
matter of this CRADA
8. Avoidance of Conflict of Interests and Assurance of Fair
NIH has implemented the FTTA with strict attention to Federal conflict
of interest and ethic laws, as well as various Departmental and
NIH regulations. Additionally, the Public Health Service has issued
guidelines for PHS agencies in order to assure fair access to our
laboratories and consideration for CRADAs. Completion and signature
certification of the following conflict of interest disclosure and
fair access assurance form by only the NIH Principal Investigator
is mandatory prior to review of a proposed CRADA by the CRADA Subcommittee.